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ROWAN UNIVERSITY

 

Title: Biosafety

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and Dual Use Research Concern Policy 
Subject: Research
Policy No: Res: 02/28/2018
Applies: University-Wide
Issuing Authority: President
Responsible Officers:  Vice Chancellor for Research and Sr. Vice President for Facilities Planning and Operations
Adopted: 2010
Last Revision: 09/19/2025
Last Reviewed: 02/05/2026

 

I. PURPOSE

The purpose of this policy is to describe  the University’s adherence to multiple federal requirements surrounding obligations prescribed by: 1) the Office of Science and Policy NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines, 2024) (e.g., for the safe use of potentially biohazardous, mutagenic, genotoxic, teratogenic, neurotoxic and hyper-allergenic agents), and 2) the Office of Science and Policy guidelines on research with high-consequence pathogens and toxins to determine and assess impacts to public health, agriculture, food security, economic security, or national security as established by the Unites States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern. These federal guidelines mandate Rowan’s adherence triggered by the University receiving federal sponsored funds. Rowan will implement these requirements to the degree required as a recipient of federal funds.


II. ACCOUNTABILITY

Under direction of the President, Sr. Vice President for Facilities Planning and Operations and the Vice Chancellor for Research, Rowan University shall implement and ensure compliance with this policy. The Vice Chancellor for Research functions as the Institutional Official and may delegate that role as appropriate.


III. APPLICABILITY

Rowan University will apply this policy to all biohazardous agents/materials and recombinant or synthetic nucleic acid molecules research conducted at Rowan University. This policy also applies to any use of biohazardous agents/materials that may be a dual use of research concern.

Rowan University has established an Institutional Biosafety Committee (IBC) and appropriate policies and procedures for the effectiveness of the IBC. . Policies and procedures include, but are not limited to, initial and continuing review and approval of applications, proposals, and activities involving use and storage of recombinant or synthetic nucleic acid molecules and biohazardous agents/materials research conducted at Rowan University. Rowan University is not participating in or sponsoring recombinant or synthetic nucleic acid molecule research involving human subjects.


IV. DEFINITIONS

  1. Biocontainment - the containment of pathological microorganisms within a well-defined, strictly controlled area, usually a research laboratory.
  2. Biohazard - a biological agent, such as an infectious microorganism or a biological toxin, or a condition that constitutes a threat to humans, especially in biological research or experimentation. The potential danger, risk, or harm from exposure to such an agent or condition.
  3. Biosafety – The application of knowledge, techniques and equipment to prevent personal, laboratory and environmental exposure to potentially infectious and recombinant materials. 
  4. Biosafety Level - The level of the biocontainment precautions required to isolate dangerous biological agents in an enclosed laboratory facility. The levels of containment range from the lowest biosafety level 1 (BSL-1) to the highest at level 4 (BSL-4). In the United States, the Centers for Disease Control and Prevention (CDC) have specified these levels.
  5. Biosafety Officer - The designated scientific-administrative officer who assures compliance and biosafety of research involving biohazards and/or recombinant and synthetic nucleic acids.
  6. BMBL - “Biosafety in Microbiological and Biomedical Laboratories” (BMBL) is produced by the Centers for Disease Control and Prevention (CDC), Office of Health and Safety and the National Institutes of Health to provide national guidelines to promote the safety and health of workers in biological and medical laboratories.
  7. Dual Use Research of Concern (DURC) – life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be misapplied to do harm with no, or only minor, modification to pose a significant threat with potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security.
  8. Environmental Safety and Health – A discipline and specialty that studies and implements practical aspects of environmental protection and safety at work. In simple terms it is what organizations must do to make sure that their activities do not cause harm to anyone.
  9. Exposure Control – A plan that is important to help protect workers from exposures to blood and other body fluids also known as Bloodborne pathogen exposure control
  10. Institutional Official –  Senior Officer of Rowan University with authority to establish the Institutional Biosafety Committee (IBC) and oversight of the administration and operations of the IBC.
  11. Institutional Biosafety Committee (IBC) - institutional body responsible for oversight of activities involving biohazardous materials as required by the National Institutes of Health Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) and the Centers for Disease Control and Prevention (CDC) Biosafety in Microbiological and Biomedical Laboratories (BMBL).
  12. Institutional Contact for Dual Use Research (ICDUR) - is the official designated by the research institution to serve as an internal resource for application of this Policy as well as the liaison (as necessary) between the institution and the relevant federal funding agency.
  13. Institutional Review Entity – Subcommittee of the IBC and responsible for review of biological agents or toxins subject to U.S. Government, NIH Policy on Dual Use of Research Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP).
  14. Life Sciences- pertains to living organisms (e.g., microbes, human beings, animals, and plants) and their products, including all disciplines and methodologies of biology such as aerobiology, agricultural science, plant science, animal science, bioinformatics, genomics, proteomics, microbiology, synthetic biology, virology, molecular biology, environmental science, public health, modeling, engineering of living systems, and all applications of the biological sciences. The term is meant to encompass the diverse approaches to understanding life at the level of ecosystems, populations, organisms, organs, tissues, cells, and molecules. Life sciences is defined in United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (2014 Institutional DURC Policy).
  15. OSHA - an injury or illness is considered by the Occupational Safety and Health Administration to be work-related if an event or exposure in the work environment either caused or contributed to the resulting condition or significantly aggravated a pre-existing condition.
  16. Pathogen with Pandemic Potential (PPP) - is a pathogen that is likely capable of wide and uncontrollable spread in a human population and would likely cause moderate to severe disease and/or mortality in humans.
  17. PEOSH - Public Employees Occupational Safety and Health (PEOSH) develops and enforces occupational health standards for public employees and encourages employers and employees to improve their working environment.
  18. Principal Investigator - (PI) The lead researcher for the project and is responsible for research compliance regulations at the laboratory level.
  19. Recombinant DNA Technology – The process of taking a gene or a DNA fragment from one organism and inserting into the genome of another.  One commonly used technology involves the insertion of a new fragment of DNA that codes for a specific protein such as a growth hormone gene transferred into and expressed by a bacterium.
  20. Risk Group - The classification of biological agents into the four risk groups applies for both so-called natural biological agents and genetically modified organisms. This takes into consideration pathogenicity of the organism, mode of transmission and host range, and also taking into consideration effective preventive measures and availability of effective treatment. 
  21. Select Agents – Biological substances (agents) declared by the U.S. Department of Health and Human Services (HHS) or by the U.S. Department of Agriculture (USDA) to have the "potential to pose a severe threat to public health and safety".
  22. Synthetic Nucleic Acids - Molecules that are constructed by joining naturally-occurring nucleic acid molecules and that can integrate and replicate into the genome of a living cell (i.e., recombinant nucleic acids) or nucleic acid molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but that are complementary to and can form base pairs with naturally occurring nucleic acid molecules , or molecules that result from the replication of recombinant or synthetic nucleic acids.
  23. USDA/APHIS - United States Department of Agriculture, Animal and Plant Health Inspection Service, a multi-faceted Agency with a broad mission area that includes protecting and promoting U.S. agricultural health, regulating genetically engineered organisms, administering the Animal Welfare Act and carrying out wildlife damage management activities.

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